http://www.hindawi.com/journals/jir/2014/796856/ They are being planned. Glioblastoma is going to need a full therapeutic process like most cancers but the brain area is even a harder area. I expect the REACT study to show continual efficacy and not off the chart numbers but something that continues to speak of a needed therapy or tool for GBM. Personally if the numbers and tumor responses are partially better than standard of care it would be hard not to seek approval. GBM is not friendly to overall survival numbers and progression free in previous trials this could be a small dilemma like most trials but it is more than evident there is a robust response in EGFR111 with titers and tumors response.
If they do not beat this quarter they have severe problems, did you see the well results this quarter and the one brought on late. If we fail we have a huge depletion problem. That is what I am really waiting to see. We had a good 15 to 20 wells with high IP rates
Who is playing the beat in results for WLL and KOG to increase WLL share price? I am thinking estimates are not baked into WLL based on current quarter. IF Peterson and company beat expectations handily that should send WLL into the 90's. Thoughts?
This has nothing more than to do with depletion rates and the share count both fears I had for owning this stock have come true again. Peterson is full of it.
What is so positive if we continue to see GPNMB show response in those with high expressions this could lead to shorter trials and quicker approval. Essentially we are identifying a paradigm shift.
Anybody have any guesses on 2nd quarter production numbers. We have seen alot of wells released with some high IP numbers? This quarter in my opinion is a big tell tell on the depletion of the wells and we are heading into next quarter with one year data on the projects.
I believe this is what is as well triggering more of the combination studies or mechanism of action combinations. The FDA hinted to this about a year or so ago and I believe it is coming as well. Essentially the FDA will say we just want to see one product with a mechanism of action on a target and not 5 or 6 look a likes.
These stock remain high on my Radar screen. TKMR Tekmira, this could be a 100 dollar stock one day.
Aquinox Pharmaceuticals and Conatus Pharmaceuticals. I would also include Arrow as well. What others are you seeing as a nice opportunity.
Conatus may be the super sleeper here I am learning more about their product but in multi billion dollar potential area.
I still like Idera and I would look at Mast Therapeutics for a high risk play. APHB is my favorite penny stock. SYN could have some serious potential if they can get funding and research inline.
If you read in between the lines of what Celldex is saying they are saying mechanism of action is what the FDA is looking for as well. If you remember the FDA made a statement a few months back about limiting the study of oncology drugs with the same mechanism of action. Essentially when you listen to Celldex they are telling mechanism of action with efficacy will continue to grow in combination therapy. The thought will be to throw complimentary actions rather than running the body in the ground and hope you can recover. This is why Celldex is so bullish about their products and they are a good 2 to 5 years ahead of others and as well very diiferent mechanism of action.
I fully anticipate a BRAC inhiibitors signing like that with BMS. Celldex did not give up much because essentially the FDA is going to want these studies 10 years from now over dual mechanism of action and how they work. Get the picture they are moving forward. Combination studies use to be done in phase 4 now we are seeing them signed and mentioned in early data and study concepts.
It does matter because of the estimates and ramp efficiency. I am surprised they are showing efficiency and really want to see if they can build enough product for inventory as well. Estimates are around what 162 million, I think if we are above 145 million this is a very good quarter.
Yes a very small one and really looking more into the pipeline down the road. I have followed SYN and many of the XON holdings for a couple of years even before XON was a traded company. Mr. Kirk is from my area and I am familiar with his story. For SYN I really invested for the C. Diff product and other pipeline. It would thrill me for this product to make the market but you wonder if physicians just take some of the data and do their own combinations moving forward. I would hope a partner would come along and want to partner the product. I am sure they are wanting to partner this or find a quick approval path through the FDA for pre-approved products.
To me this type of data is very common in a phase 2 trial. You often see them under powered and not able to show total endpoints. Phase 2 trial here looks very efficient for neuroprotection. When your dealing with MS it is a disease that showing primary power is not always easy but it is doable.
The neuroprotective benefits of the combination will probably prove to be the smoking gun and patient benefit. The study in itself is a benefit to the medical community and will be interesting to see what happens moving forward. If greater patient enrollment is what it takes to power the trial and demonstrate p value and neuroprotection then it should be successful.
There are other estriols being developed because the hormone was always under utilized and under appreciated.
I hope I read the charts right and the 13.92 range is it and its not the 12 range. Should have known with the know good news for awhile this is the risk. Alot of news was out the first of the year with ISIS, ALNY, CLDX, ARWR, TKMR and now some has dried up and they are punishing these stocks. I think the 1135 debacle left alot of wonder in the efficacy of the products. We need a win over the next few months. Any kinda of approval for Rindo or 011 and this is a 30 dollar stock overnight. 1127 needs to show efficacy for this trend to turn. Still way to much in the pipeline. I would also favor some non-oncology assets to bolster the depth of the company. That was the beauty of the 1135 product and the others in the pipeline. We need to have something non-oncology and also good data to reset the trend if not it could be painful for awhile.
You have to read the charts and level of support. Hedge funds operate on 5 and 10 day trading patterns. When they see blood in the water they pull out 3 month, 6 month 1 and 2 year charts and when you do that you see the highest level of supports at 12.30 range and we should know in the next few days. Watch and see if they try like a 15.09 range to 13.87. This stock float is to low and with Asco coming up they will play the momentum news and control it.
Well here is the fear factor being placed into CLDX right now. After the 1135 issue many questioned the intent of the outcomes or product. Then there was another article floating around that 1127 is not very potent and needs other combination products to be successful. Then we all have to be honest that Rindo is in a very tough tough disease state and has great early data but will probably be tested to the max to get a smooth approval. This is the reason for the stocks tumbling. Essentially I still believe in CLDX antibodies usually are very good products its just a matter of finding the right combinations. I will be curious to see how the market moves forward. I have always said this stock is going to have 1 to 2 dollar days because of the low float and share count not off the charts.
Essentially now we have a challenge to that 12 area starring us in the face. I even thought at 38 there was a chance at 18 again and the chart does have that 12 range written all over it and there is an apparent attack on many stocks just not bio but hedge funds to re accumulate or accumulate possible market driven stocks. I do not think Bio is overpriced the problem is when you lose in biotech you have nothing left because the product is gone but then you never get whats its worth in the growth stage because all the money is being paid for expenses. It is a very hard game and oncology market is going to be hardest to play in my opinion after the 2016 market. Over 60 percent of drugs in research are for cancer. We need some good data and get this back into the 2 billion range or so and that would be fair value with the potential to move much higher.